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510(k) Data Aggregation

    K Number
    K000547
    Device Name
    ATR TECNIKA
    Manufacturer
    ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P.
    Date Cleared
    2000-05-03

    (75 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991401
    Device Name
    ATR 3000, ATR 2000, IMPLANT-PRO
    Manufacturer
    ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P.
    Date Cleared
    1999-12-15

    (237 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATR Surgical Micromotors are intended to prepare intraoral bone for implantology procedures.
    Device Description
    The ATR Surgical Micromotors are microprocessor driven surgical micromotors used in implantology procedures. The ATR Surgical Micromotors consist of a microprocessor control unit, foot pedal, electric micromotor, support rods and sterile irrigation tubes. The microprocessor unit also houses the peristaltic pump. The ATR Surgical Micromotors provide electronic control of velocity and torque. The ATR Surgical Micromotors can be programmed and retains up to five programs in memory. The ATR Surgical Micromotors are also fully operational from the foot pedal. The foot pedal not only controls the functions of the ATR Surgical Micromotors, but it can also be used for programming.
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